Aclaris Therapeutics Reports First Quarter 2022 Financial Results and Provides a Corporate Update
May 10 2022 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced its
financial results for the first quarter of 2022 and provided a
corporate update.
“We have continued to progress our clinical programs, including
activating multiple clinical sites in our Phase 2b trial of
ATI-1777 in subjects with moderate to severe atopic dermatitis,”
said Dr. Neal Walker, President and CEO of Aclaris. “We look
forward to advancing all of our clinical and preclinical
programs.”
Research and Development Highlights:
Clinical Programs
- Zunsemetinib, an investigational oral small
molecule MK2 inhibitor:Currently being developed as a potential
treatment for immuno-inflammatory diseases
- ATI-450-RA-202: This Phase 2b dose ranging
trial to investigate the efficacy, safety, tolerability,
pharmacokinetics and pharmacodynamics of multiple doses (20 mg and
50 mg twice daily) of zunsemetinib in combination with methotrexate
in subjects with moderate to severe rheumatoid arthritis (RA) is
ongoing.
- Aclaris expects topline data in 2023.
- ATI-450-HS-201: This Phase 2a trial to
investigate the efficacy, safety, tolerability, pharmacokinetics
and pharmacodynamics of zunsemetinib (50 mg twice daily) in
subjects with moderate to severe hidradenitis suppurativa (HS) is
ongoing.
- Aclaris expects topline data in the first half of 2023.
- ATI-450-PsA-201: Aclaris expects to activate
clinical sites in the coming weeks in this Phase 2a trial of
zunsemetinib (50 mg twice daily) in subjects with moderate to
severe psoriatic arthritis.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developing as a
potential treatment for moderate to severe atopic dermatitis (AD)
- ATI-1777-AD-202: Aclaris activated multiple
clinical sites in May 2022 in this Phase 2b trial to determine the
efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in
subjects with moderate to severe AD. In this trial, Aclaris will
explore multiple concentrations of twice daily treatment with
ATI-1777 and a single concentration of once daily treatment with
ATI-1777, in patients 12 years and older.
- Aclaris expects topline data in the first half of 2023.
- ATI-2138, an investigational oral ITK/TXK/JAK3
(ITJ) inhibitor:Currently being developed as a potential treatment
for T cell-mediated autoimmune diseases
- ATI-2138-PKPD-101: This Phase 1 single
ascending dose (SAD) trial to investigate the safety, tolerability,
pharmacokinetics and pharmacodynamics of ATI-2138 in healthy
subjects is ongoing.
- Aclaris expects topline data in 2022.
- If the Phase 1 SAD trial is successful, Aclaris currently plans
to initiate a two-week Phase 1 multiple ascending dose trial of
ATI-2138 in subjects with psoriasis in 2022. Aclaris is also
currently exploring alternative indications to the planned
indication that are relevant to the mechanism of action.
Preclinical Programs
- ATI-2231, an investigational oral MK2
inhibitor compound: Currently being explored as a potential
treatment for pancreatic cancer and metastatic breast cancer as
well as in preventing bone loss in patients with metastatic breast
cancer
- Second MK2 inhibitor generated from Aclaris’ proprietary
KINect® drug discovery platform and designed to have a long
half-life.
- IND-enabling studies are underway, and Aclaris expects to
submit an IND by the end of 2022.
Discovery Programs
- Currently developing oral gut-biased JAK inhibitors with
limited systemic exposure as potential treatments for inflammatory
bowel disease.
- Central nervous system (CNS) kinase inhibitor targets:
- Currently engaged in research to identify brain penetrant
kinase inhibitor candidates and assess their impact on neuronal
pro-inflammatory cytokine production, microglia growth and
survival, and neurodegeneration.
Other Highlights
Aclaris continues to expand its senior R&D team and recently
appointed Ian Anderson, Ph.D., as Executive Vice President,
Translational Research & Development, and Rob Ortmann, M.D., as
Vice President, Clinical Development. Dr. Anderson brings more than
30 years of immunology research experience in drug development,
from discovery through Phase 2. He previously held senior
scientific leadership roles at Flame Biosciences, Janssen
Pharmaceutical, MedImmune and Cambridge Antibody Technology. Dr.
Ortmann is a board-certified rheumatologist with more than 10 years
of clinical research experience in autoimmune-related therapeutic
areas. He previously held clinical development positions at Horizon
Therapeutics and Eli Lilly and Company.
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2022, Aclaris had aggregate cash, cash
equivalents and marketable securities of $204 million compared to
$226 million as of December 31, 2021. Additionally, in April 2022,
Aclaris sold approximately 4.8 million shares under its ATM
facility for aggregate net proceeds of $73 million.
Aclaris now anticipates that its cash, cash equivalents and
marketable securities as of March 31, 2022 in combination with the
$73 million in net proceeds from the April 2022 ATM sale will be
sufficient to fund its operations through the end of 2025, without
giving effect to any additional potential business development
transactions or financing activities.
Financial Results
First Quarter 2022
- Net loss was $18.8 million for the first quarter of 2022
compared to $28.8 million for the first quarter of 2021.
- Total revenue was $1.5 million for the first quarter of 2022
compared to $1.8 million for the first quarter of 2021.
- Research and development (R&D) expenses were $14.3 million
for the quarter ended March 31, 2022 compared to $7.8 million for
the prior year period.
- The $6.5 million increase was primarily the result of:
- Higher zunsemetinib development expenses, including costs
associated with clinical activities for a Phase 2b trial for RA and
a Phase 2a trial for HS.
- Higher ATI-1777 development expenses related to drug candidate
manufacturing and other preclinical activities and start-up costs
associated with a Phase 2b clinical trial.
- Higher preclinical development activities related to
ATI-2231.
- General and administrative (G&A) expenses were $6.1 million
for the quarter ended March 31, 2022 compared to $4.8 million for
the prior year period.
- The $1.3 million increase was primarily the result of higher
compensation-related costs, including stock-based compensation, due
to increased headcount and the impact of new equity awards granted
during the first quarter of 2022.
- Revaluation of contingent consideration resulted in a $1.2
million credit for the quarter ended March 31, 2022 compared to a
contingent consideration charge of $16.4 million for the prior year
period.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing a pipeline of novel drug candidates to address
the needs of patients with immuno-inflammatory diseases who lack
satisfactory treatment options. The company has a multi-stage
portfolio of drug candidates powered by a robust R&D engine
exploring protein kinase regulation. For additional information,
please visit www.aclaristx.com.
Cautionary Note Regarding Forward-Looking
Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,”
and similar expressions, and are based on Aclaris’ current beliefs
and expectations. These forward-looking statements include
expectations regarding the development of Aclaris’ drug candidates,
including the timing of its clinical trials and regulatory filings,
and its belief that its existing cash, cash equivalents and
marketable securities will be sufficient to fund its operations
through the end of 2025. These statements involve risks and
uncertainties that could cause actual results to differ materially
from those reflected in such statements. Risks and uncertainties
that may cause actual results to differ materially include
uncertainties inherent in the conduct of clinical trials, Aclaris’
reliance on third parties over which it may not always have full
control, Aclaris’ ability to enter into strategic partnerships on
commercially reasonable terms, the uncertainty regarding the
COVID-19 pandemic and other risks and uncertainties that are
described in the Risk Factors section of Aclaris’ Annual Report on
Form 10-K for the year ended December 31, 2021, and other filings
Aclaris makes with the U.S. Securities and Exchange Commission from
time to time. These documents are available under the “SEC Filings”
page of the “Investors” section of Aclaris’ website at
www.aclaristx.com. Any forward-looking statements speak only as of
the date of this press release and are based on information
available to Aclaris as of the date of this release, and Aclaris
assumes no obligation to, and does not intend to, update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Aclaris Therapeutics,
Inc.Condensed Consolidated Statements of
Operations(unaudited, in thousands, except share and per share
data)
|
Three Months Ended |
|
March 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
Contract research |
$ |
1,221 |
|
|
$ |
1,535 |
|
Other revenue |
|
232 |
|
|
|
242 |
|
Total revenue |
|
1,453 |
|
|
|
1,777 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue(1) |
|
1,155 |
|
|
|
1,202 |
|
Research and development(1) |
|
14,306 |
|
|
|
7,838 |
|
General and administrative(1) |
|
6,099 |
|
|
|
4,827 |
|
Revaluation of contingent consideration |
|
(1,200 |
) |
|
|
16,439 |
|
Total costs and expenses |
|
20,360 |
|
|
|
30,306 |
|
Loss from operations |
|
(18,907 |
) |
|
|
(28,529 |
) |
Other income (expense), net |
|
118 |
|
|
|
(225 |
) |
Net loss |
$ |
(18,789 |
) |
|
$ |
(28,754 |
) |
Net loss per share, basic and
diluted |
$ |
(0.31 |
) |
|
$ |
(0.57 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
61,431,026 |
|
|
|
50,337,807 |
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
$ |
228 |
|
|
$ |
247 |
|
Research and development |
|
(113 |
) |
|
|
876 |
|
General and administrative |
|
2,231 |
|
|
|
1,552 |
|
Total stock-based compensation
expense |
$ |
2,346 |
|
|
$ |
2,675 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
203,577 |
|
|
$ |
225,656 |
|
Total assets |
$ |
226,527 |
|
|
$ |
251,211 |
|
Total current liabilities |
$ |
16,726 |
|
|
$ |
22,931 |
|
Total liabilities |
$ |
46,328 |
|
|
$ |
53,870 |
|
Total stockholders' equity |
$ |
180,199 |
|
|
$ |
197,341 |
|
Common stock outstanding |
|
61,737,483 |
|
|
|
61,228,446 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Cash Flow Data(unaudited, in
thousands)
|
|
|
|
|
|
|
March 31, 2022 |
|
March 31, 2021 |
|
|
|
|
|
|
Net loss |
$ |
(18,789 |
) |
|
$ |
(28,754 |
) |
Depreciation and
amortization |
|
208 |
|
|
|
288 |
|
Stock-based compensation
expense |
|
2,346 |
|
|
|
2,675 |
|
Revaluation of contingent
consideration |
|
(1,200 |
) |
|
|
16,439 |
|
Changes in operating assets and
liabilities |
|
(3,534 |
) |
|
|
(2,880 |
) |
Net cash used in operating
activities |
$ |
(20,969 |
) |
|
$ |
(12,232 |
) |
Aclaris Contact
investors@aclaristx.com
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Apr 2023 to Apr 2024